OncoMatch/Clinical Trials/NCT04240054
Bortezomib, Isatuximab, Cyclophosphamide and Dexamethasone Induction in Transplant-Eligible Multiple Myeloma Patients With Renal Insufficiency
Is NCT04240054 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Bortezomib and Isatuximab for multiple myeloma.
Treatment: Bortezomib · Isatuximab · Cyclophosphamide · Dexamethasone — This is a single-arm, open-label phase II study with a safety lead-in phase.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: multiple myeloma-directed therapy
Exception: dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m^2), and/or cyclophosphamide up to 500 mg/m^2 administered for management of acute manifestations of MM for no longer than four weeks prior to enrollment
No prior multiple myeloma (MM) -directed therapy except for dexamethasone (up to 160 mg), bortezomib (up to 5.2 mg/m^2) and/or cyclophosphamide up to 500 mg/m^2 administered for management of acute manifestations of MM (hypercalcemia, renal impairment, pain) for no longer than four weeks prior to enrollment.
Lab requirements
Blood counts
Absolute neutrophil count ≥1.0 × 10^9/L (no G-CSF in past 7 days); hemoglobin >7.5 g/dL (blood transfusions allowed to maintain >7.5 g/dL); platelet count ≥75 × 10^9/L for subjects with <50% plasma cells in marrow, otherwise ≥50 × 10^9/L (no platelet transfusions in past 7 days)
Kidney function
Renal insufficiency: eGFR < 40 mL/min/1.73m^2 (based on MDRD formula) for Cohort A; exclusion if requires immediate treatment for renal failure (e.g., dialysis) until stable
Liver function
ALT <2.5 × ULN, AST <2.5 × ULN, total bilirubin <1.5 × ULN (except for Gilbert Syndrome: direct bilirubin <2 × ULN)
Cardiac function
No clinically significant cardiac disease (MI within 6 months, unstable angina, CHF NYHA III-IV, uncontrolled arrhythmia NCI-CTCAE v5 Grade 2+, QTcF >470 msec, uncontrolled hypertension)
Any of the following laboratory test results at the time of enrollment: Absolute neutrophil count <1.0 × 10^9/L; hemoglobin ≤7.5 g/dL; platelet count <75 × 10^9/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise platelet count <50 × 10^9/L; ALT ≥2.5 × ULN; AST ≥2.5 × ULN; total bilirubin ≥1.5 × ULN, (except for Gilbert Syndrome: direct bilirubin ≥2 × ULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, Wisconsin
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04240054 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages